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Deflector Resector
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref JSBDR3235
by Joimax GmbH
Identity
- Trade Name
- Deflector Resector EUDAMEDFDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Deflector Resector EUDAMEDFDA UDIDeflector Diamond Abrasor EUDAMED
- Model / Reference
- JSBDR3235 EUDAMEDFDA UDI
- Description
- Deflector Resector FDA UDI
Identifiers
- Catalog Number
- JSBDR3235 FDA UDI
- Primary DI / UDI-DI
- 04250337103257 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337103257 EUDAMED42503371DEFLCUT9S EUDAMED
- Direct Marketing DI
- 04250337103257 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Arthroscopic shaver system blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Spinal shaver system blade
Deflector Resector by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal shaver system blade.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337103257 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337103257 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 6d4d8957-73f6-4dd4-b72f-511e76d295d0 61 fields · synced Jul 27, 2026
- FDA UDI 3505eff7-4e45-41dd-b8c7-fc32902ef0a6 36 fields · synced May 30, 2026
- EUDAMED 7b949137-bac4-43cb-aefd-4c777f00eeef 61 fields · synced Jul 13, 2026